{
"NDC": [
{
"NDCCode": "0179-0184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0179-0184-30)",
"NDC11Code": "00179-0184-30",
"ProductNDC": "0179-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076578",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0179-0184-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0179-0184-15)",
"NDC11Code": "00179-0184-15",
"ProductNDC": "0179-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076578",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10544-184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (10544-184-30)",
"NDC11Code": "10544-0184-30",
"ProductNDC": "10544-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: : 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "13668-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-184-30) ",
"NDC11Code": "13668-0184-30",
"ProductNDC": "13668-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090865",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis)."
},
{
"NDCCode": "14445-184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30) ",
"NDC11Code": "14445-0184-30",
"ProductNDC": "14445-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218445",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
},
{
"NDCCode": "21695-184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-184-30)",
"NDC11Code": "21695-0184-30",
"ProductNDC": "21695-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Razadyne",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021169",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H -benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C17H21NO3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. RAZADYNE® ER is available in opaque hard gelatin extended-release capsules of 8 mg (white), 16 mg (pink), and 24 mg (caramel) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide and sugar spheres (sucrose and starch). The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide. RAZADYNE® for oral use is available in circular biconvex film-coated immediate-release tablets of 4 mg (off-white), 8 mg (pink), and 12 mg (orange-brown). Each 4, 8, and 12 mg (base equivalent) tablet contains 5.126, 10.253, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake. RAZADYNE® is also available as a 4 mg/mL oral solution. The inactive ingredients for this solution are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, sodium hydroxide and purified water."
},
{
"NDCCode": "27241-184-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-184-30) ",
"NDC11Code": "27241-0184-30",
"ProductNDC": "27241-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20210119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213271",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210119",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile."
},
{
"NDCCode": "33261-184-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (33261-184-30)",
"NDC11Code": "33261-0184-30",
"ProductNDC": "33261-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076001",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor indicated for: : 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) , 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) , 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) , 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).",
"Description": "Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the following structural formula. C17H18F3NOHCl M.W. 345.79. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: ammonium hydroxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "43063-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-184-30)",
"NDC11Code": "43063-0184-30",
"ProductNDC": "43063-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20111110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020733",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "8; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "43353-184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-184-30) ",
"NDC11Code": "43353-0184-30",
"ProductNDC": "43353-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130919",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091226",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160602",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "43742-0184-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0184-1)",
"NDC11Code": "43742-0184-01",
"ProductNDC": "43742-0184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pre Dental Visit",
"NonProprietaryName": "Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121012",
"EndMarketingDate": "20180418",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; SMILAX REGELII ROOT; ORNITHOGALUM UMBELLATUM FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID",
"StrengthNumber": "3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43857-0184-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0184-1)",
"NDC11Code": "43857-0184-01",
"ProductNDC": "43857-0184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Alb",
"NonProprietaryName": "Candida Albicans",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130612",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "CANDIDA ALBICANS",
"StrengthNumber": "500",
"StrengthUnit": "[hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2017-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170509",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of gas with abdominal discomfort after eating, mood swings, joint pains, irritability, forgetfulness, skin rashes, and fatigue."
},
{
"NDCCode": "44911-0184-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (44911-0184-1)",
"NDC11Code": "44911-0184-01",
"ProductNDC": "44911-0184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cardio Tonic",
"NonProprietaryName": "Cactus Grandiflorus, L-carnitine, Strophanthus Hispidus, Borago Officinalis, Linum Usitatissimum, Heart (suis), Kali Carbonicum, Kali Nitricum, Thyroidinum (suis), Adonis Vernalis, Digitalis Purpurea, Lycopus Virginicus,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150708",
"EndMarketingDate": "20200724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Energique, Inc.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; LEVOCARNITINE; STROPHANTHUS HISPIDUS SEED; BORAGE; FLAX SEED; PORK HEART; POTASSIUM CARBONATE; POTASSIUM NITRATE; SUS SCROFA THYROID; ADONIS VERNALIS; DIGITALIS; LYCOPUS VIRGINICUS",
"StrengthNumber": "3; 3; 3; 4; 4; 6; 6; 6; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-25",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "45865-184-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30) ",
"NDC11Code": "45865-0184-30",
"ProductNDC": "45865-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200503",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3."
},
{
"NDCCode": "49288-0184-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0184-4)",
"NDC11Code": "49288-0184-04",
"ProductNDC": "49288-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elm Mixture",
"NonProprietaryName": "Elm Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN",
"StrengthNumber": ".025; .025",
"StrengthUnit": "g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "50845-0184-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (50845-0184-1) ",
"NDC11Code": "50845-0184-01",
"ProductNDC": "50845-0184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unique Pain Reduction Arthritis",
"NonProprietaryName": "Aconitum Napellus, Apis Mellifica, Benzoicum Acidum, Cartilago Suis, Colchicum Autumnale, Eupatorium Perfoliatum, Guaiacum, Hypericum Perforatum, Ledum Palustre, Mercurius Corrosivus, Rhus Tox, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"EndMarketingDate": "20220107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Liddell Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; BENZOIC ACID; SUS SCROFA CARTILAGE; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 200; 6; 3; 200; 200; 3; 200; 6; 200; 200; 200",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151210",
"EndMarketingDatePackage": "20220107",
"SamplePackage": "N"
},
{
"NDCCode": "51407-184-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-184-30) ",
"NDC11Code": "51407-0184-30",
"ProductNDC": "51407-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rabeprazole Sodium",
"NonProprietaryName": "Rabeprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090678",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "N",
"IndicationAndUsage": "Rabeprazole Sodium Delayed-Release Tablets are a proton pump inhibitor (PPI) indicated in adults for: 1 Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). , 2 Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). , 3 Treatment of Symptomatic GERD ( 1.3). , 4 Healing of Duodenal Ulcers ( 1.4). , 5 Helicobacter pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.5). , 6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). .",
"Description": "The active ingredient in Rabeprazole Sodium Delayed-Release Tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H-benzimidazole sodium salt. It has an empirical formula of C 18H 20N 3NaO 3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is:. Rabeprazole Sodium Delayed-Release Tablets are available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are crospovidone, FD&C Blue #1, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc and triethyl citrate."
},
{
"NDCCode": "53217-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (53217-184-30)",
"NDC11Code": "53217-0184-30",
"ProductNDC": "53217-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071321",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate."
},
{
"NDCCode": "54575-184-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (54575-184-30)",
"NDC11Code": "54575-0184-30",
"ProductNDC": "54575-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspergillus Niger",
"NonProprietaryName": "Aspergillus Niger Var. Niger",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS NIGER VAR. NIGER",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "58118-0184-8",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0184-8) ",
"NDC11Code": "58118-0184-08",
"ProductNDC": "58118-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"EndMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Clinical Solutions Wholesale, LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170104",
"EndMarketingDatePackage": "20181201",
"SamplePackage": "N"
},
{
"NDCCode": "59651-184-30",
"PackageDescription": "6 POUCH in 1 CARTON (59651-184-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "59651-0184-30",
"ProductNDC": "59651-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211888",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240729",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
"Description": "Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "60429-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (60429-184-30) ",
"NDC11Code": "60429-0184-30",
"ProductNDC": "60429-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075657",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131104",
"SamplePackage": "N"
},
{
"NDCCode": "66336-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (66336-184-30)",
"NDC11Code": "66336-0184-30",
"ProductNDC": "66336-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040412",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch."
},
{
"NDCCode": "69968-0184-1",
"PackageDescription": "30 mL in 1 BOTTLE (69968-0184-1) ",
"NDC11Code": "69968-0184-01",
"ProductNDC": "69968-0184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Skinclearing",
"ProprietaryNameSuffix": "Oil Free Makeup - Fresh Beige 70",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150901",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150901",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "70518-0184-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-0184-0) ",
"NDC11Code": "70518-0184-00",
"ProductNDC": "70518-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076161",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170127",
"SamplePackage": "N"
},
{
"NDCCode": "70934-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70934-184-30) ",
"NDC11Code": "70934-0184-30",
"ProductNDC": "70934-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202557",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181025",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0184-1",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0184-1) ",
"NDC11Code": "71335-0184-01",
"ProductNDC": "71335-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180905",
"SamplePackage": "N"
},
{
"NDCCode": "72189-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72189-184-30) ",
"NDC11Code": "72189-0184-30",
"ProductNDC": "72189-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078420",
"LabelerName": "direct rx",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210511",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. It has the following structure. [structure1]. Nabumetone is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Tablets for Oral Administration: Each white coloured, oval shaped, biconvex, film coated tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients consists of hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and opadry white OY 58900 [hypromellose, polyethylene glycol 400, and titanium dioxide]."
},
{
"NDCCode": "72865-184-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-184-30) ",
"NDC11Code": "72865-0184-30",
"ProductNDC": "72865-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210105",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "82804-184-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (82804-184-30) ",
"NDC11Code": "82804-0184-30",
"ProductNDC": "82804-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250102",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0179-0184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0179-0184-30)</PackageDescription>
<NDC11Code>00179-0184-30</NDC11Code>
<ProductNDC>0179-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076578</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0179-0184-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0179-0184-15)</PackageDescription>
<NDC11Code>00179-0184-15</NDC11Code>
<ProductNDC>0179-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076578</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10544-184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10544-184-30)</PackageDescription>
<NDC11Code>10544-0184-30</NDC11Code>
<ProductNDC>10544-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: : 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>13668-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-184-30) </PackageDescription>
<NDC11Code>13668-0184-30</NDC11Code>
<ProductNDC>13668-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090865</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
</NDC>
<NDC>
<NDCCode>14445-184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30) </PackageDescription>
<NDC11Code>14445-0184-30</NDC11Code>
<ProductNDC>14445-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218445</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>21695-184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-184-30)</PackageDescription>
<NDC11Code>21695-0184-30</NDC11Code>
<ProductNDC>21695-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Razadyne</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021169</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H -benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C17H21NO3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. RAZADYNE® ER is available in opaque hard gelatin extended-release capsules of 8 mg (white), 16 mg (pink), and 24 mg (caramel) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide and sugar spheres (sucrose and starch). The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide. RAZADYNE® for oral use is available in circular biconvex film-coated immediate-release tablets of 4 mg (off-white), 8 mg (pink), and 12 mg (orange-brown). Each 4, 8, and 12 mg (base equivalent) tablet contains 5.126, 10.253, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake. RAZADYNE® is also available as a 4 mg/mL oral solution. The inactive ingredients for this solution are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>27241-184-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-184-30) </PackageDescription>
<NDC11Code>27241-0184-30</NDC11Code>
<ProductNDC>27241-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213271</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>33261-184-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (33261-184-30)</PackageDescription>
<NDC11Code>33261-0184-30</NDC11Code>
<ProductNDC>33261-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076001</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor indicated for: : 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) , 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2) , 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) , 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
<Description>Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the following structural formula. C17H18F3NOHCl M.W. 345.79. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: ammonium hydroxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43063-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-184-30)</PackageDescription>
<NDC11Code>43063-0184-30</NDC11Code>
<ProductNDC>43063-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20111110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020733</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-184-30) </PackageDescription>
<NDC11Code>43353-0184-30</NDC11Code>
<ProductNDC>43353-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130919</StartMarketingDate>
<EndMarketingDate>20200731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091226</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160602</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-0184-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0184-1)</PackageDescription>
<NDC11Code>43742-0184-01</NDC11Code>
<ProductNDC>43742-0184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pre Dental Visit</ProprietaryName>
<NonProprietaryName>Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121012</StartMarketingDate>
<EndMarketingDate>20180418</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; SMILAX REGELII ROOT; ORNITHOGALUM UMBELLATUM FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43857-0184-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0184-1)</PackageDescription>
<NDC11Code>43857-0184-01</NDC11Code>
<ProductNDC>43857-0184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Alb</ProprietaryName>
<NonProprietaryName>Candida Albicans</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>CANDIDA ALBICANS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of gas with abdominal discomfort after eating, mood swings, joint pains, irritability, forgetfulness, skin rashes, and fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44911-0184-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (44911-0184-1)</PackageDescription>
<NDC11Code>44911-0184-01</NDC11Code>
<ProductNDC>44911-0184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cardio Tonic</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, L-carnitine, Strophanthus Hispidus, Borago Officinalis, Linum Usitatissimum, Heart (suis), Kali Carbonicum, Kali Nitricum, Thyroidinum (suis), Adonis Vernalis, Digitalis Purpurea, Lycopus Virginicus,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150708</StartMarketingDate>
<EndMarketingDate>20200724</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Energique, Inc.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; LEVOCARNITINE; STROPHANTHUS HISPIDUS SEED; BORAGE; FLAX SEED; PORK HEART; POTASSIUM CARBONATE; POTASSIUM NITRATE; SUS SCROFA THYROID; ADONIS VERNALIS; DIGITALIS; LYCOPUS VIRGINICUS</SubstanceName>
<StrengthNumber>3; 3; 3; 4; 4; 6; 6; 6; 6; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>45865-184-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30) </PackageDescription>
<NDC11Code>45865-0184-30</NDC11Code>
<ProductNDC>45865-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200503</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>49288-0184-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0184-4)</PackageDescription>
<NDC11Code>49288-0184-04</NDC11Code>
<ProductNDC>49288-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elm Mixture</ProprietaryName>
<NonProprietaryName>Elm Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN</SubstanceName>
<StrengthNumber>.025; .025</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>50845-0184-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (50845-0184-1) </PackageDescription>
<NDC11Code>50845-0184-01</NDC11Code>
<ProductNDC>50845-0184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unique Pain Reduction Arthritis</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Apis Mellifica, Benzoicum Acidum, Cartilago Suis, Colchicum Autumnale, Eupatorium Perfoliatum, Guaiacum, Hypericum Perforatum, Ledum Palustre, Mercurius Corrosivus, Rhus Tox, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<EndMarketingDate>20220107</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Liddell Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; BENZOIC ACID; SUS SCROFA CARTILAGE; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>200; 200; 6; 3; 200; 200; 3; 200; 6; 200; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151210</StartMarketingDatePackage>
<EndMarketingDatePackage>20220107</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-184-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-184-30) </PackageDescription>
<NDC11Code>51407-0184-30</NDC11Code>
<ProductNDC>51407-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rabeprazole Sodium</ProprietaryName>
<NonProprietaryName>Rabeprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090678</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rabeprazole Sodium Delayed-Release Tablets are a proton pump inhibitor (PPI) indicated in adults for: 1 Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). , 2 Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). , 3 Treatment of Symptomatic GERD ( 1.3). , 4 Healing of Duodenal Ulcers ( 1.4). , 5 Helicobacter pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.5). , 6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). .</IndicationAndUsage>
<Description>The active ingredient in Rabeprazole Sodium Delayed-Release Tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H-benzimidazole sodium salt. It has an empirical formula of C 18H 20N 3NaO 3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is:. Rabeprazole Sodium Delayed-Release Tablets are available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are crospovidone, FD&C Blue #1, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>53217-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53217-184-30)</PackageDescription>
<NDC11Code>53217-0184-30</NDC11Code>
<ProductNDC>53217-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071321</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>54575-184-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (54575-184-30)</PackageDescription>
<NDC11Code>54575-0184-30</NDC11Code>
<ProductNDC>54575-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Niger</ProprietaryName>
<NonProprietaryName>Aspergillus Niger Var. Niger</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS NIGER VAR. NIGER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>58118-0184-8</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0184-8) </PackageDescription>
<NDC11Code>58118-0184-08</NDC11Code>
<ProductNDC>58118-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<EndMarketingDatePackage>20181201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59651-184-30</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (59651-184-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>59651-0184-30</NDC11Code>
<ProductNDC>59651-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211888</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
<Description>Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>60429-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (60429-184-30) </PackageDescription>
<NDC11Code>60429-0184-30</NDC11Code>
<ProductNDC>60429-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075657</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66336-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (66336-184-30)</PackageDescription>
<NDC11Code>66336-0184-30</NDC11Code>
<ProductNDC>66336-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040412</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69968-0184-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (69968-0184-1) </PackageDescription>
<NDC11Code>69968-0184-01</NDC11Code>
<ProductNDC>69968-0184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Skinclearing</ProprietaryName>
<ProprietaryNameSuffix>Oil Free Makeup - Fresh Beige 70</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150901</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70518-0184-0</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-0184-0) </PackageDescription>
<NDC11Code>70518-0184-00</NDC11Code>
<ProductNDC>70518-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076161</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70934-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70934-184-30) </PackageDescription>
<NDC11Code>70934-0184-30</NDC11Code>
<ProductNDC>70934-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202557</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0184-1</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0184-1) </PackageDescription>
<NDC11Code>71335-0184-01</NDC11Code>
<ProductNDC>71335-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72189-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72189-184-30) </PackageDescription>
<NDC11Code>72189-0184-30</NDC11Code>
<ProductNDC>72189-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078420</ApplicationNumber>
<LabelerName>direct rx</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. It has the following structure. [structure1]. Nabumetone is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Tablets for Oral Administration: Each white coloured, oval shaped, biconvex, film coated tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients consists of hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and opadry white OY 58900 [hypromellose, polyethylene glycol 400, and titanium dioxide].</Description>
</NDC>
<NDC>
<NDCCode>72865-184-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-184-30) </PackageDescription>
<NDC11Code>72865-0184-30</NDC11Code>
<ProductNDC>72865-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>82804-184-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (82804-184-30) </PackageDescription>
<NDC11Code>82804-0184-30</NDC11Code>
<ProductNDC>82804-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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